System and a method for managing information relating to sample test requests within a laboratory environment

ABSTRACT

A system and method for managing information relating to requests for a number of tests to be made of at least one sample within a laboratory environment are disclosed. The system may include a sample reception unit, a pre-analytical unit to scan, sort and/or aliquot the sample on request according to respective test requirements included within a respective sample order, an analytical unit to run at least one test on a sorted and/or aliquoted sample, and at least one decision unit. The decision unit acts as a connecting component for interconnecting the sample reception unit, the pre-analytical unit and the analytical unit as both an intermediary and coordinator such that tests can be performed via a recursive workflow until the sample is completely measured. The decision unit is further configured to collate the test results appropriately with the sample and to give a respective report towards a host component.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/277,681, filed Nov. 25, 2008, which is a continuation ofInternational Application No. PCT/EP2007/004581, filed 23 May 2007,which claims priority to EP Application No. 06011422.0, filed Jun. 1,2006, which are herein incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to data management within alaboratory environment and more particularly, to a system and a methodfor managing information relating to requests for a number of tests tobe made on at least one sample within a laboratory environment.

BACKGROUND OF THE INVENTION

In some current laboratory environments, an increased amount of sampleshave to be handled. They have to be tested with respect to a broad rangeof different properties. Those laboratories have particularly a lot ofdifferent instruments for automated sample preparation and for automatedanalysis. Those laboratory processes include pre-analytical, analyticaland post-analytical steps and require at the same time powerful datamanagement functions. Therefore, it is a pre-requisite for optimizing acomplete laboratory process to combine those pre-analytical, analyticaland post-analytical decisions with data management functions. Moreover,it would be desirable to provide one uniform backbone to realizeadvanced sample workflows in a uniform manner to increase laboratoryefficiency and to deliver high quality results. Simultaneously, it wouldbe desirable, that the complexity of such laboratory processes isreduced, while improving quality and providing a satisfying workenvironment.

SUMMARY OF THE INVENTION

Therefore, the present disclosure provides a system and a method, whichallow small to very large laboratory sites, as for example moleculardiagnostic sites, to realize customer solutions combining fully computeraided sample handling functions with data management decisions.

Those laboratory sites have, as already mentioned, typically one or moreunits for sample preparation and one or more units for analysis, e.g. incase of molecular diagnostic laboratories for amplification anddetection.

According to one embodiment, a system for managing information relatingto requests for a number of tests to be made on at least one samplewithin a laboratory environment is disclosed. The system comprises atleast one pre-analytical unit, which is configured to scan the at leastone sample and to sort and/or aliquot the at least one sample on requestaccording to respective test requirements, at least one analytical unitconfigured to run at least one test of the number of tests on theappropriately sorted and/or aliquoted sample and a decision unitenabling at least one host component to access the system and to submitthe sample order, and acting as connecting component for interconnectingthe at least one pre-analytical unit and the at least one analyticalunit and as intermediary and coordinator in communication between thoseunits, such that the number of tests can be performed via a workflow,such as via a recursive workflow, coordinated by the decision unit untila pre-given stopping criterion is fulfilled, such as until the sample iscompletely measured, the decision unit being further configured tocollate the test results appropriately with the sample and to give arespective report towards the at least one host component.

In a further embodiment, a decision unit for managing informationrelating to requests for a number of tests to be made on at least onesample in a system within a laboratory environment is disclosed. Thesystem within the laboratory environment comprises at least onepre-analytical unit and at least one analytical unit. The decision unitenables at least one host component to access the system and to submit asample order for the at least one sample. Furthermore, the decision unitacts as a connection component for interconnecting the at least onepre-analytical unit and the at least one analytical unit and asintermediary and coordinator in communication between those units, suchthat the number of tests can be performed via a workflow, such as via arecursive workflow, coordinated by the decision unit, until a pre-givencriterion is fulfilled, such as until the sample is completely measured.The decision unit is further configured to correlate the test resultsappropriately with the sample and to give a respective report towardsthe at least one host component.

A further embodiment refers to a method for managing information relatedto requests for a number of tests to be made on at least one sample in asystem within a laboratory environment, the system within the laboratoryenvironment comprising at least one pre-analytical unit, at least oneanalytical unit and one decision unit. The method comprises: receivingthe sample, transporting the sample to the at least one pre-analyticalunit, identifying the sample and assigning the sample to a sample order,processing the sample according to the sample order by a dynamicallyadaptable coordinated interaction of the at least one pre-analyticalunit and the at least one analytical unit, and giving a report about theprocessing to at least one host component, wherein the coordinationbetween the respective units is managed by the decision unit acting asintermediary and coordinator in communication between the respectiveunits and the report is given by the decision unit acting asconsolidating front end related to the at least one host component.

The present invention also relates in one embodiment to acomputer-readable medium with a computer program stored thereon, thecomputer program comprising a program code, which is suitable forcarrying out a method according to the disclosure when the computerprogram is run on a computer, such as on a computer integrated within asystem and/or a decision unit according to the present disclosure.

Further features and embodiments will become apparent from thedescription and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic block diagram of a possible embodiment of asystem according to the present disclosure,

FIG. 2 shows a schematic block diagram of a further embodiment of asystem according to the present disclosure,

FIG. 3 shows a flowchart of an embodiment of the method according to thepresent disclosure,

FIG. 4 shows a flowchart of a further embodiment of the method accordingto the present disclosure, and

FIG. 5 shows a schematic simple recursive workflow realizable by anembodiment of the system according to the present disclosure.

DETAILED DISCUSSION

For purposes of clarity, the present discussion refers to an abstractexample of a system. However, the method and the system of the presentdisclosure may operate with a wide variety of types of systems includingnetworks and communication systems dramatically different from thespecific example as illustrated in the drawings.

It should be understood that while the following is described in termsof a specific system, that there are applications in a variety ofcommunication systems, such as advanced medical laboratory systems,advanced laboratory networks or any other communication system thatwould benefit from the system or the method according to the presentdisclosure. It is intended that the system as used in the specificationand claims is suitable to be used in any communication system unless thecontext requires otherwise.

An implementation is schematically illustrated in the drawings by way ofan example embodiment and is explained in detail with reference to thedrawings. It is understood that the description is in no way limiting onthe scope of the present disclosure and is merely an illustration of anexample implementation.

In the following, similar components are referred to by equal referencenumbers.

FIG. 1 shows a block diagram of an embodiment of the system according tothe present disclosure. The system 100 comprises a decision unit 10, atleast one pre-analytical unit 20, at least one analytical unit 30 and atleast one post-analytical unit 40. The possibility of a multiplicity ofthe respective units is indicated by an appropriate enumeration and bysuccessively arranged boxes, respectively. The decision unit 10 isfurther connected with a database 11 as indicated by link A. Thedatabase 11 can also be integrated within the decision unit 10. Thedecision unit 10 is connected, as indicated by link B, with at least oneor more host components 200. Via standard host interface protocols, e.g.ASTM or HL7, the decision unit 10 can communicate with at least one hostcomponent 200 with a standard function set. No specific logic has to berealized in the host system. Therefore, it can be integrated fast, easyand with low risk.

During runtime of the system 100, a sample order comprising a sample-IDand sample test requests can be downloaded from at least one hostcomponent 200 to the decision unit 10 of the system 100 via standardinterface protocols. Sample test request information and sampleinformation, optionally including other sample and patient demographicinformation, which is included in the sample order, is stored in thelocal database 11 of the decision unit 10. A sample in form of a sampletube 50 is arriving, as indicated on the left side of FIG. 1, in thepre-analytical unit 20. A sample scan is preformed by the pre-analyticalunit 20 which is sent via link C to the decision unit 10.

The decision unit 10 is downloading to the pre-analytical unit 20 vialink C sample information, i.e. an appropriate target information orpending test requests which are included in the sample order. Dependingon the downloaded sample information, e.g. target or pending tests, theat least one pre-analytical unit 20 is performing the required action,i.e. sorting or aliquoting the sample tube 50, and putting the sampletube 50 into an appropriate target. The pre-analytic sorting/aliquotinginformation is uploaded (e.g. in form of an extended sample order) vialink C to the decision unit 10. The sorted aliquoted sample tube 50 isput via link D on the analytical unit 30.

Either in batch or in query mode the analytical unit 30 is asking vialink E for the appropriate test request information from the decisionunit 10. The decision unit 10 is downloading via link E the extendedsample order including the corresponding information to the analyticalunit 30. After the corresponding test(s) has (have) been done by theanalytical unit 30, the test results are uploaded from the analyticalunit 30 via link E to the decision unit 10.

The decision unit 10 updates the sample order with respect to theuploaded test results. That means that the decision unit 10 processesthe test results, derives therefrom open and/or pending test requests,decides about further actions and initiates those actions, if necessary.Furthermore, the decision unit 10 updates the sample order stored withinthe database 11. The decision unit 10 can comprise a rule engine 12 bymeans of which that coordination functionality of the decision unit 10can be supported. The rule engine 12 can be an off-the-shelf rule enginecapable of handling facts and applying inference rules on those facts.The inference rules can be defined in advance and dynamically adapted tonew circumstances.

The rule engine can add new or confirmation tests based on current testresults, current test result flags, other sample information, such assample quality, sample volume, sample turn around time, sample loadbalancing rules, previous sample results, etc., and/or patient relatedinformation, such as age, gender, location information, requester/ward,etc., or this test or any other requested test can be commented,blocked, released, replaced, modified or extended, e.g. by comments orflags.

The sample tube 50 is either immediately processed by the analyticalunit 30 as indicated by backwardly directed arrow I, in case theanalytical unit has the capabilities or the sample tube 50 is put backon one of the pre-analytical units 20 as indicated by backwardlydirected arrow F.

The pre-analytical unit 20 is scanning the sample unit 50 again andsends the scan via link C to the decision unit 10. In case of stillpending test requests, the decision unit 10 is downloading again theappropriate test request or target information via link C to thepre-analytical unit 20 and the described steps are repeated until alltest requests/targets have been done and no open test request/target isexisting.

Then, the sample tube 50 is sorted via link G into an archive tray bythe at least one post-analytical unit 40, which is informed by thedecision unit 10 via link H.

By means of the system 100, it is possible to realize that no specialworkflow logic has to be implemented into the host component 200. Whilelinks A, B, C, E and H describe communication links enabling therespective units to transfer information data among each other, forexample by using appropriate interface protocols, respectively, links D,F, G and I correspond to transporting connections for the sample tube50.

The host component 200 is relieved from any real-time duties as allrequired decisions, i.e. pre-analytical, analytical and post-analyticaldecisions are taken by the decision unit 10. High quality results can bedelivered by proven process units within the system 100 and complexalgorithms do not have to be implemented in the host component 200. Thelaboratory process as described above can be optimized by combiningsample flow related decisions as pre-analytical, analytical andpost-analytical steps with data management information as received testresults optionally combined with available sample and patientinformation within the decision unit 10. Via standard host interfaceprotocols, e.g. ASTM or HL7, those workflow and data managementfunctions can be integrated fast, easy and with low risk into anexisting laboratory environment. This reduces the complexity, improveslaboratory quality and provides a satisfying work environment.

The system is scalable and extendable as pre-analytical, analytical andpost-analytical units can be added based on the throughput and turnaround time requirements. This can be done without change of theinterface between the host component 200 and the decision unit 10.

It is possible to provide a plurality of pre-analytical units 20,wherein all of the pre-analytical units have the same functionality andperform the same task on a sample. Therefore, it is possible to handle aplurality of samples 1 to n in parallel. That means, for example, thatsamples 1 to i are handled by pre-analytical unit 20_1, whereas samplesi+1 to n are handled by pre-analytical unit 20_2. This can be continuedanalogically in case of more than two pre-analytical units.

Alternatively, it is possible to provide a plurality of pre-analyticalunits 20, wherein each of the pre-analytical units can perform certainsteps in the pre-analytical processing of a sample, thus thepre-analytical units complement one another with respect to the wholepre-analytical processing. That means, for example, in case of m stepswhich have to be done in the pre-analytical processing, that steps 1 toi are done for all samples by pre-analytical unit 20_1, whereas stepsi+1 to m are performed by pre-analytical unit 20_2. The assignment ofsteps can be modified accordingly in case of more than twopre-analytical units.

FIG. 2 describes a further block diagram of an embodiment of the systemaccording the present disclosure. The system 100 comprises a decisionunit 10, at least one analytical unit 30 and at least one further unit25 in which a pre-analytical unit and a post-analytical unit arecombined. The decision unit 10 is again connected via a link A with adatabase 11 which can also be an integral part of the decision unit 10.The decision unit 10 can communicate with at least one host component200 via a standard interface protocol, as indicated by link B. Thedecision unit 10 can also communicate with the pre- and post-analyticalunit 25 and with the analytical unit 30 via appropriate interfaceprotocols, respectively, as indicated by links C, E and H. As indicatedon the left side a sample tube 50 is arriving in the pre- andpost-analytical unit 25 where a sample scan is performed and sent to thedecision unit 10. Based on the scan the decision unit 10 is downloadingan appropriate sample order including a sample-ID and either the sampletest request or target information, optionally combined with availablesample and patient information, which is stored in the local database 11of the decision unit 10. The stored sample order optionally combinedwith other information has been downloaded before from the hostcomponent 200 to the decision unit 10 of the system 100 via standardinterface protocols.

Depending on the downloaded sample order/sample target information, thepre- and post analytical unit 25 is performing a required action, as forexample sorting or aliquoting, and putting the sample tube 50 into anappropriate target. The sample order can be extended by the pre-analyticsorting/aliquoting information. Such extended sample order in terms ofsample information, e.g. sample extension, sample position or any otherinformation, is uploaded via link C from the pre- and post-analyticalunit 25 to the decision unit 10. The sorted/aliquoted sample tube 50 isput via connection D on the analytical unit 30.

The analytical unit 30 is asking via link E for appropriate test requestinformation from the decision unit 10. The analytical unit 30 is askingfor such information either in batch mode or in query mode. The decisionunit 10 is downloading the sample order or the extended sample order,which is to be understood in the broadest sense of sample informationcomprising the required information, to the analytical unit 30. Afterthe required test has been done the test results are uploaded from theanalytical unit 30 to the decision unit 10.

The decision unit 10 updates the sample order with respect to theuploaded test results. The decision unit 10 can add new or confirmationtests based on current test results, current test result flags, othersample information, such as sample quality, sample volume, sample turnaround time, sample load balancing rules, previous sample results, etc.,and/or patient related information, such as age, gender, locationinformation, requester/ward, etc., or this test or any other requestedtest can be commented, blocked, released, replaced, modified orextended, e.g. by comments or flags. The sample tube 50 is eitherimmediately processed by the analytical unit 30 as indicated bybackwardly directed arrow I, in case the analytical unit has thecapabilities, or the sample tube 50 is put back on the pre- andpost-analytical unit 25 as indicated by backwardly directed arrow F. Thepre- and post-analytical unit is scanning the sample tube 50 again andthe scan is sent to the decision unit 10.

In case of still pending sample test requests, the before mentionedsteps are repeated until all sample test requests have been done or noopen target is existing on the sample tube 50. In case no open testrequests are existing or no open target is existing, the sample tube 50is sorted into an archive tray by the pre- and post analytical unit 25.

FIG. 3 shows a flowchart of an embodiment of the method according to thepresent disclosure. The method as described hereinafter can be used inlarge molecular diagnostics sites. Those sites have typically one ormore instruments for automated sample preparation and one or moreautomated amplification and detection instruments. Instruments forautomated sample preparation are provided for example by COBASAmpliPrep™ Instruments of Roche Diagnostics. As automated amplificationand detection instruments COBAS TaqMan™ Analyser, COBAS TaqMan 48™Analyser or COBAS Amplicor™ Analyser, all distributed by RocheDiagnostics, can be used. A number of the laboratories are using one ormore so-called Hamilton Star™ for automated pipetting of primary sampletubes to so-called S-tubes of the mentioned COBAS AmpliPrep™ Instrument.These laboratories are running for example virology assays forHIV/HBV/HCV testing. The Hamilton system in a workflow as it is providedby an embodiment of the method according to the present disclosure canbe used as an aliquot system generating out of a bar-coded primarysample tube an aliquot in a so-called SK 24 rack. The Hamilton system isnot used as a pooling system. The decision unit as a part of anembodiment of the system according to the present disclosure manages theworkflow described hereinafter and required data information transferbetween the different units. The decision unit manages in a moleculardiagnostics workflow an interface to a host component, a data flowbetween the so-called Hamilton system and any analytical unit,hereinafter called Amplilink™ data stations, and collates test resultswith the corresponding sample tubes and reports sample and/or test orderstatus towards a corresponding host component.

In the case described in FIG. 3, a sample order is generated in a hostcomponent 200. The sample order consists of a unique sample ID and anumber of test requests. The sample order, namely the sample-ID and thetest requests, is downloaded to the decision unit 10 as a part of asystem 100. One or more pre-analytical units 20, which can be a Hamiltonsystem, is sending a query to the decision unit 10 as soon as a sampletube has been scanned on the pre-analytical unit 20. The decision unit10 is sending via link C the sample order, including a specimen-ID plusthe sample test requests, to the pre-analytical unit 20. Thepre-analytical unit 20 is processing the sample order. Depending on thetest requests, sample material is pipetted in a rack, such as a SK-rack.The pre-analytical unit 20 is extending the sample order by the rack-IDand the rack-position. The extended sample order is uploaded via link Cto the decision unit 10.

Alternatively, the sample order, that means the sample-ID plus the testrequests, can also be entered directly into the pre-analytical unit 20,e.g. by loading the corresponding samples, assorted by test parameters.Therefore, the decision unit 10 must be able to handle unknown sampleorders uploaded by the pre-analytical unit 20. The host component 200must also be able to handle unknown samples, that means sample-ID plussample test results, uploaded by the decision unit 10 at the end of thetest process.

The decision unit 10 is receiving the extended sample order, namely thesample-ID, the sample-ID modified, the rack-ID, the rack-position andthe test requests. The decision unit 10 is forwarding the sample orderaccording to the rack-ID, received by the pre-analytical unit 20 and anassigned rack-range in case of multiple connections to appropriateanalytical units 30 via respective links E_1, . . . , E_N. Thoseanalytical units 30 can be assorted by rack-range as indicated by thenumeration 30_1 to 30_N. In the case shown here, the analytical unit30_1 handles rack range A to M, while the analytical unit 30_N handlesrack range N-Z. The analytical unit 30_1 is processing the sample ordersrelating to rack ranges A to M. The analytical unit 30_N processes thesample orders relating to rack ranges N to Z. After having performed thecorresponding tests, the respective analytical unit 30 is uploading viarespective link E the sample order and the test results to the decisionunit 10 including flags and comments. The decision unit 10 is updatingthe sample order with respect to the received test results. The decisionunit 10 is uploading the updated sample order, including the testresults to the host component 200. Such an upload can be performedaccording to predefined rules. The decision unit 10 can uploading theupdated sample order periodically to the host component, thus informingthe host component about the actual sample order/result status.Alternatively, the host component is only informed by a sample orderupload when all test requests have been done. In case that there arestill pending test requests, the decision unit 10 downloads again thesample order, including sample test results(s) and pending testrequest(s) via link C to the pre-analytical unit 20.

In the case shown here, racks must be pre-sorted by the laboratory,considering the target system the test requests are performed.

FIG. 4 shows a further flowchart of another embodiment of the methodaccording to the present disclosure.

A sample order is again generated in a host component 200. The sampleorder consists of a unique sample-ID and a number of test requests to bemade on the corresponding sample. The sample order, namely the sample-IDand the test requests, is downloaded to a decision unit 10, which ispart of a system 100. One or more pre-analytical units 20, which is alsoincluded within system 100, is sending a query to the decision unit 10as soon as the sample has been scanned on the pre-analytical unit 20.The decision unit 10 is sending via link C the sample order to thepre-analytical unit 20. The pre-analytical unit 20 is processing thesample order. Depending on the test requests, sample material ispipetted in an appropriate rack, which can be for example a so-calledSK-24 rack. The pre-analytical unit 20 is extending the sample order bya rack-ID and a rack-position. The extended sample order is uploaded vialink C to the decision unit 10.

As already mentioned in connection with FIG. 3, sample orders can alsobe entered directly on the pre-analytical unit 20, e.g. by loadingsamples, assorted by test parameters. Therefore, the decision unit 10,as well as the host component 200, must be able to handle unknown sampleorders uploaded by the pre-analytical unit 20 and the decision unit 10,respectively.

The decision unit 10 is receiving the extended sample order, includingthe sample-ID, a sample-ID modified, a rack-ID, a rack-position and testrequests. The decision unit 10 is forwarding via batch download thesample order to all analytical units 30_1, . . . , 30_N, which areconnected with the decision unit 10 via links E_1, . . . , E_N,respectively. The respective analytical unit 30_i among the plurality ofanalytical units 30, which is receiving the SK-24 rack is processing thesample order. This analytical unit 30_i is uploading the sample orderand the test results to the decision unit 10, including flags andcomments. After the decision unit 10 has received the complete sample,the decision unit is sending a cancel request via respective links E_jto the other analytical units 30_j (i≠j) to delete an appropriate orderautomatically out of a local analytical data base. The decision unit 10is updating the sample order with respect to the test results anduploading the updated sample order including the test results to the atleast one host component 200. In case that there are still pending testrequests, the decision unit 10 downloads again the sample order,including sample test results(s) and pending test request(s) via link Cto the pre-analytical unit 20.

In the case shown here, no rack pre-sorting is required, contrary to thescenario shown in connection with FIG. 3. Overlapping test panes in caseof multi analytical unit connections are supported.

FIG. 5 shows a recursive workflow which can be realized within anembodiment of the system according to the present disclosure. A simplerecursive workflow, based on test requests only, is implemented betweena pre-analytical unit, herein after called Hamilton, a decision unit,called PSM, and an analytical unit, called Amplilink. Such a recursiveworkflow means, in the example shown here, that only the remaining testrequests, which have not been processed up to now, are considered. Ifall tests have been done an appropriate flag is sent to thepre-analytical unit, acting as a sample preparation unit. Optionallycompletely processed samples can then go into archive. In case that therequested sample is not known by the decision unit, an appropriate flagis sent to the pre-analytical unit.

The example shown in FIG. 5 describes a sample “123” with test requests“T1/T2/T3/T4”. The at least one pre-analytical unit Hamilton asks viaquery 1 the decision unit PSM for sample “123”. As an answer, which issent from the decision unit PSM to the pre-analytical unit Hamilton, asample-ID “123” with test requests “T1/T2/T3/T4” is provided. Thepre-analytical Hamilton performs pre-analytical actions, e.g. pipetting,and sends the result back to the decision unit PSM for sample “123”,which reads “sample-ID 123 T1;R-ID/R-Pos/123”. In reaction to such aresult, the sample is forwarded to an appropriate analytical unit forprocessing test request T1. Via a query 2, the at least onepre-analytical unit Hamilton asks the decision unit PSM for sample“123”. As an answer, the decision unit PSM sends to the pre-analyticalunit Hamilton where the sample is put on the sample-ID “123” with testrequests “T2/T3/T4”, since T1 has been already processed successfully.As a result, the pre-analytical unit Hamilton where the sample is put onperforms the pre-analytical action (pipetting) and sends the result backto the decision unit PSM, which reads the “sample-ID 123 T2;R-ID/R-Pos/123”. In reaction of such a result, the sample “123” isforwarded by the decision unit PSM to an appropriate analytical unit,which processes test request T2. After that, the at least onepre-analytical unit Hamilton asks again via query 3 the decision unitPSM for sample “123”. The decision unit PSM answers by providing thesample-ID “123” with test request “T3/T4”. The pre-analytical Hamiltonwhere the sample is put on makes pipetting for sample “123” and sendsthe results back to the decision unit PSM, which reads “sample-ID 123T3,T4;R-ID/R-Pos/123”. Therefore, the sample is forwarded to ananalytical unit, which is capable of processing test requests T3, T4.After that, the sample is forwarded back to the at least onepre-analytical unit Hamilton, which asks via query 4 the decision unitPSM again for sample “123”. The decision unit provides thepre-analytical unit with information of the sample “123”, namely thesample-ID “123”, with no test requests left. That means, that in thiscase, an empty record is sent back, so that the pre-analytical unitHamilton does not perform any further action. The sample can then beforwarded to a post-analytical unit in which the sample can be archived.Such a post-analytical unit can be consolidated with a pre-analyticalunit within a common physical device.

According to one embodiment, a system for managing information relatingto requests for a number of tests to be made on at least one sample 50within a laboratory environment is disclosed. The system comprises atleast one pre-analytical unit 20 configured to scan the at least onesample 50 and to sort, aliquot and/or archive the at least one sample 50on request according to respective test requirements included within arespective sample order, at least one analytical unit 30 configured torun at least one test of the number of tests on the appropriately sortedand/or aliquoted sample 50, and a decision unit 10 enabling at least onehost component 200 to access the system and to submit the sample orderfor the at least one sample, and acting as intermediary and coordinatorin communication between the at least one pre-analytical unit 20 and theat least one analytical unit 30 such that the number of tests can beperformed via a recursive workflow until a pre-given stopping criterionis fulfilled, the decision unit 10 being further configured to collategained test results appropriately with the sample 50 and to give arespective report towards the at least one host component 200.

The system can also comprise in another embodiment at least one samplereception unit configured to receive the at least one sample.

In a further embodiment, a decision unit 10 for managing information inreal-time relating to requests for a number of tests to be made on atleast one sample 50 in a system within a laboratory environment isdisclosed. The laboratory environment comprising at least onepre-analytical unit 20 and at least one analytical unit 30, wherein thedecision unit 10 enables at least one host component to access thesystem and to submit a sample order for the at least one sample, andacts as intermediary and coordinator in communication between thepre-analytical unit 20 and the analytical unit 30 such that the numberof tests can be performed via a recursive workflow, coordinated by thedecision unit 10 until a pre-given stopping criterion is fulfilled, thedecision unit 10 being further configured to collate gained test resultsappropriately with the sample 50 and to give a respective report towardsthe at least one host component 200.

The decision unit 10 in one embodiment is combining the informationcoming from the different units, e.g. from the at least onepre-analytical unit 20 and the at least one analytical unit 30, as abasis to make a next decision.

The decision unit 10 itself in one embodiment can be configured tooptionally combine current analytical data, such as current analyticaltest result information with other sample related information to decidethe next pre-analytical step. Sample related information is to beunderstood within the scope of the present specification in a broadsense, including sample specific information, such as sample quality,sample volume, sample turn around time, sample load balancinginformation, delta checks with previous results, and/or patient relateddemographic information, such as age, gender, location information,requester/ward etc.

A further embodiment refers to a method for managing informationrelating to requests for a number of tests to be made on at least onesample within a laboratory environment, the laboratory environmentcomprising at least one pre-analytical unit 20, at least one analyticalunit 30 and a decision unit 10. The method comprises: receiving thesample, transporting the sample to the at least one pre-analytical unit20, identifying the sample and assigning the sample to a sample order,processing the sample according to the sample order by a dynamicallyadaptable coordinated interaction of the at least one pre-analyticalunit 20 and the at least one analytical unit 30, and giving a reportabout the processing to at least one host component 200, wherein thecoordination between the at least one pre-analytical unit 20 and the atleast one analytical unit 30 is managed by the decision unit 10 actingas intermediary and coordinator in communication between the respectiveunits and the report is given by the decision unit 10 acting asconsolidating front end related to the at least one host component 200.

The processing in one embodiment can be done via a recursive workflow.

In another embodiment, the recursive workflow comprises: processing thesample order by the at least one pre-analytical unit by sorting and/oraliquoting the sample and putting the sample into an appropriate target,putting the sorted and/or aliquoted sample on the at least oneanalytical unit, depending on the sample order with the sample testrequest information and the sample related information, downloaded fromthe decision unit to the analytical unit, performing at least oneappropriate test among the number of tests by the analytical unit,uploading the test results from the analytical unit to the decisionunit, updating the sample order with respect to the uploaded testresults at the decision unit, and repeating at least some of the stepsuntil a pre-given stopping criterion is fulfilled.

When a test is performed, the test results are sent back to the decisionunit. At the decision unit, the sample order is accordingly updated withrespect to the uploaded test results, i.e. by current test resultinformation and with respect to further current sample relatedinformation. The test result information can comprise all still open orpending test requests in one embodiment. The further current samplerelated information can comprise any information describing situationalinterests in another embodiment. Optionally, new tests or confirmationtests can be generated by the decision unit based on current testresults, current result flags, previous sample results, any otherpatient related demographic information, such as gender, age, requester,etc. or the test just made or any other requested test can be commented,blocked, released, replaced, modified or extended, e.g. with comments orflags. Failed tests which have to be repeated can also be included inanother embodiment. The updated sample order is processed again until apre-given stopping criterion is reached. Such a stopping criterion canbe fulfilled, e.g. when all test requests have been done in oneembodiment.

One embodiment of the method further comprises receiving the sampleorder comprising a sample-ID and the sample test requests with sampletest request information and sample related information from the atleast one host component. That means that the sample order comprisingthe sample-ID and the test requests is downloaded from the at least onehost component to the decision unit. In that case, it is conceivable,that the pre-analytical unit is sending a query to the decision unitafter the sample received at the pre-analytical unit has been scanned.The decision unit sends the sample order to the pre-analytical unit. Thepre-analytical unit processes the sample order by sorting and/oraliquoting the sample, depending on the sample test request information,and by putting the sample as a sample tube into an appropriate target.It is possible, for example, that depending on the sample test requestinformation sample material is pipetted into an appropriate secondarytube which is assigned to an appropriate rack and target.

Alternatively, in another embodiment, it is also possible that thesample order is directly received by the pre-analytical unit. That meansthat the sample order can be directly entered on the pre-analyticalunit, e.g. by loading sample tubes assorted by test parameters. In thatcase the decision unit must be able to handle unknown sample ordersuploaded by the pre-analytical unit.

According to one embodiment, the system further comprises at least onepost-analytical unit, configured to archive measured samples. Thepost-analytical unit is an equipment used to perform post-analyticalfunctions in a respective laboratory, as for example archiving ofsamples. The equipment in one embodiment can be a robot system doing therequired post-analytical steps.

It is also possible, that the post- and the pre-analytical units in oneembodiment are consolidated within one common physical equipment.

The decision unit according to another embodiment provides oneconsolidating and standardized front end for all pre-analytical,analytical and post-analytical units of the system related to one ormore existing host systems. Those host systems are relieved fromreal-time duties.

The system according to another embodiment provides one backbone torealize advanced sample workflows, thus increasing laboratory efficiencyand delivering high quality results. The system allows to combinepre-analytical, analytical and post-analytical decisions with datamanagement functions as automatic result validation rules. This is, asalready mentioned above, a pre-requisite for optimizing the completelaboratory process.

It is possible within a further embodiment of the system that the systemcan communicate with at least one host component via any standard hostinterface protocol, such as via ASTM or HL7. Via such standard hostinterface protocols, and a standard function set, the system can beintegrated fast, easy and with low risk within a specific laboratoryenvironment. This reduces complexity and improves quality.

According to another embodiment of the system, the decision unit acts asa distributor unit, distributing the at least one sample to the at leastone analytical unit according to distribution criteria, which have beenconfigured by the decision unit itself executed in real-time, based onpre-analytical information from the at least one pre-analytical unitand/or on current analytical data which are optionally combined inreal-time with current result flags, other sample information, such assample quality, sample volume, sample turn around time, sample loadbalancing rules, previous sample results, etc. and/or patient relatedinformation such as age, gender, location information, requester/ward,patient demographic data, etc. Moreover, a current test or any otherrequested test can be commented, blocked, released or replaced, modifiedor extended, e.g. with comments or flags. Current analytical data meansthose data which can be derived from already performed tests andcorresponding test results.

Generally, it is possible that in one embodiment the system comprises aplurality of analytical units, enabling the system to run a plurality oftests. Those tests can be performed in parallel. Furthermore, thosetests can differ from each other. That means that the number of tests tobe made on the at least one sample can be run by different suitableanalytical units, even in parallel, if necessary.

In a further possible embodiment of the system, the at least onepre-analytical unit is further configured to put the sorted and/oraliquoted sample into an appropriate target for transfer to the at leastone analytical unit.

It is also possible in another embodiment, that the analytical unit isconfigured to receive open test requests either in query mode or inbatch mode from the decision unit.

One of the major characteristics of the recursive workflow, which can berealized by the system according to one embodiment, is that any nextaction to be done with the at least one sample, is taken at one logicalpoint. This logical point is realized by the decision unit which istypically located in a so-called sample distribution area of thelaboratory. The action itself can be a sorting step, an aliquoting step,a combined sorting and aliquoting step or an archive step. Any executionof a pre-analytical action is either automated by a robot system orsemi-automated by a computer aided manual system.

The decision unit in one embodiment can encompass or be connected with arule engine.

The major steps of a recursive workflow, as it can be provided by anembodiment of the system according to the present disclosure, can bedescribed as follows:

1. The at least one sample is arriving in a sample reception unit andtransported manually or automatically to a so-called sample distributionarea, which includes the at least one pre-analytical unit and thedecision unit.

2. In the at least one pre-analytical unit, the sample, which generallycan be identified by a barcode, is scanned either on a manual scanner incase of a manual scan place, or by a scanner in a robot system.

3. The decision unit checks, if the sample-ID, indicated by the barcode,is known. In case that the sample is known and there are still openrequests, which can be derived from a sample order, which has beenreceived by the system and stored accordingly in a database connectedwith the decision unit, the sample is distributed to an appropriate nexttarget. The distribution criteria itself have been configured, asalready indicated, in the decision unit. Pre-analytical information andcurrent analytical data can be considered in such a decision process.Optionally, new tests or confirmation tests can be generated by thedecision unit based on current test results, current result flags,previous sample results, any other patient related demographicinformation, such as gender, age, zip-code, requester, etc. or the testjust made or any other requested test can be commented, blocked,released, replaced, modified or extended, e.g. by comments or flags.

4. The sample is then transported manually or automatically on anappropriate tray or rack. The tray or rack is transported manually orautomatically from the sample distribution area to a correspondinganalytical unit, which is able to perform the required measurement.

5. The sample is put on the analytical unit. The analytical unit isreceiving the open requests included in the sample order either in queryor in batch mode from the decision unit.

6. Finally the test result from each test is uploaded to the decisionunit.

7. The decision unit is updating the sample order by current test resultinformation. Optionally, new tests or confirmation tests can begenerated in real-time by the decision unit based on current testresults, current result flags, previous sample results, any otherpatient related demographic information, such as gender, age, zip-code,requester, etc. or the test just made or any other requested test can becommented, blocked, released, replaced, modified or extended, e.g. bycomments or flags.

8. The sample is either immediately processed on the analytical unit, incase the analytical unit has the capabilities, or transported back tothe pre-analytical unit.

9. The sample is scanned again and, in case that there are still opentest requests, appropriately distributed to a further target.

10. In case that there are no open test requests left, the completelymeasured sample can be archived by a post-analytical unit.

Such a recursive workflow, which can be performed in one embodiment bymeans of a system according to the present disclosure and/or by means ofa decision unit according to the present disclosure, delivers a lot ofadvantages, some of which are summarized in the following.

The process is clear, since all sample distribution decisions are takenby the decision unit. The decision taken by the decision unit considerspre-analytical information as well as current analytical test results,if already available. Optional available sample information of patientrelated information can be considered. The recursive workflow realizes acombination of pre-analytical rule settings with analytical results,optionally combined with other sample and patient related informationwhich represent laboratory processes. The samples remain in thelaboratory until all required actions have been done. Furthermore, theprocess to be executed is easy to learn for any laboratory worker due toa clear process structure. Moreover, a fully computer aided decisionprocess and paperless working is decreasing the error rate andincreasing the quality.

The present disclosure in other embodiments further refers to a computerprogram product with a computer-readable medium and a computer programstored on the computer-readable medium with a program code which issuitable for carrying out a method according to an embodiment of thepresent disclosure when the computer program is run on a computer, suchas on a computer which is incorporated within a system according to anembodiment of the present disclosure.

The present disclosure in still other embodiments also refers to acomputer program with a program code which is suitable for carrying outa method according to an embodiment of the disclosure when the computerprogram is run on a computer, such as on a computer which isincorporated within a system according to an embodiment of the presentdisclosure.

What is claimed is:
 1. A system for realizing a workflow for performinga number of tests to be made on at least one sample within a laboratoryenvironment, the system comprising: a decision unit; at least onepre-analytical unit being configured to receive and to scan the at leastone sample and to sort, aliquot and/or archive the at least one sampleon request according to respective test requests included within arespective sample order comprising a sample-ID and sample test requests,wherein pre-analytical sorting/aliquoting information is uploaded fromthe pre-analytical unit to the decision unit and to scan the at leastone sample again when the sample is transported back to thepre-analytical unit after the sample order has been updated by thedecision unit; and a plurality of analytical units, each beingconfigured to run at least one test of the number of tests on theappropriately sorted and/or aliquoted sample and to upload the testresults to the decision unit, the decision unit enabling at least onehost to access the system and to submit the sample order for the atleast one sample, and acting as intermediary and coordinator incommunication between the at least one pre-analytical unit and theplurality of analytical units, wherein the decision unit coordinatesprocessing of the number of tests via a workflow until all tests havebeen done, the decision unit being further configured to: download thesample order comprising the sample-ID and sample test requests from theat least one host, to distribute the at least one sample to anappropriate analytical unit according to distribution criteria which areconfigured by the decision unit itself and which are based onpare-analytical information from the at least one pre-analytical unitand on test results from tests of the number of tests which have alreadybeen performed by at least one analytical unit optionally combined withother sample related information, to update the sample order withrespect to the uploaded test results arid to add new or confirmationtests and to comment, block, release, replace, modify or extend anyrequested test and: to combine current analytical data with other samplerelated information to decide a next pre-analytical step, so that theupdated sample order is to be processed again until all test requestshave been done, to collate gained test results with the sample, and togive a respective report towards the at least one host.
 2. The systemaccording to claim 1, the system further comprising at least onepost-analytical unit configured to archive measured samples as part ofthe workflow.
 3. The system according to claim 2, wherein the at leastone post- and the at least one pre-analytical units are consolidatedwithin one or more common physical equipment.
 4. The system according toclaim 1, wherein the decision unit is configured to combine currentanalytical data with other sample related information.
 5. The systemaccording to claim 1, the plurality of analytical units enabling thesystem to run, particularly in parallel, a plurality of tests,particularly a plurality of different tests.
 6. The system according toclaim 1, wherein the at least one pre-analytical unit is furtherconfigured to put the sorted and/or aliquoted sample into an appropriatetarget for transfer to the plurality of analytical units.
 7. The systemaccording to claim 1, the system further comprising at least one samplereception unit to receive the at least one sample.
 8. A method forrealizing a workflow for performing a number of tests to be made on atleast one sample in a system within a laboratory environment, the systemcomprising: a decision unit; at least one pre-analytical unit beingconfigured to receive and to scan the at least one sample and to sort,aliquot and/or archive the at least one sample on request according torespective test requests included within a respective sample ordercomprising a sample-ID and sample test requests, wherein pre-analyticalsorting/aliquoting information is uploaded from the pre-analytical unitto the decision unit and to scan the at least one sample again when thesample is transported back to the pre-analytical unit after the sampleorder has been updated by the decision unit; and a plurality ofanalytical units, each being configured to run at least one test of thenumber of tests on the appropriately sorted and/or aliquoted sample andto upload the test results to the decision unit, the decision unitenabling at least one host to access the system and to submit the sampleorder for the at least one sample, and acting as intermediary andcoordinator in communication between the at least one pre-analyticalunit and the plurality of analytical units, wherein the decision unitcoordinates processing of the number of tests via a workflow until alltests have been done, the decision unit being further configured to:download the sample order comprising the sample-ID and sample testrequests from the at least one host, to distribute the at least onesample to an appropriate analytical unit according to distributioncriteria which are configured by the decision unit itself and which arebased on pare-analytical information from the at least onepre-analytical unit and on test results from tests of the number oftests which have already been performed by at least one analytical unitoptionally combined with other sample related information, to update thesample order with respect to the uploaded test results arid to add newor confirmation tests and to comment, block, release, replace, modify orextend any requested test and: to combine current analytical data withother sample related information to decide a next pre-analytical step,so that the updated sample order is to be processed again until all testrequests have been done, to collate gained test results with the sample,and to give a respective report towards the at least one host the methodcomprising the following steps: A. receiving the simple by the at leastone sample reception unit, B. transporting the sample to the at leastone pre-analytical unit, C. identifying the sample by the of least onepre-analytical unit and assigning the sample to a sample order by thedecision unit, D. performing a sample scan by the at least onepre-analytical unit and sending the sample scan: to the decision unit,E. receiving by the decision unit the sample order comprising asample-ID and the sample test requests with sample test requestinformation and sample related information from at least one host, F.processing the sample according to the sample order by a dynamicallyadaptable coordinated interaction of the at least one pre-analyticalunit and the plurality of analytical units, wherein the at least onesample is distributed to an appropriate analytical unit according todistribution criteria which are configured by the decision unit itselfand which are based on pre-analytical information from the at least onepre-analytical unit and on test results from tests of the number oftests which have already been performed by at least one analytical unitoptionally combined with other sample related information, and whereinthe sample order: is updated with respect to uploaded test results, F′if necessary, commenting, blocking, releasing, replacing, modifying orextending any requested test by the decision unit, F″ combining, by thedecision unit, current analytical data with other sample relatedinformation to decide a next pre-analytical step, so that the updatedsample order is to be processed again until all test requests have beendone, F″′ scanning the at least one sample again, by the at least onepre-analytics unit, when the sample is transported back to thepre-analytical unit after the sample order has been updated by thedecision unit, and F″″ appropriately distributing by the decision unit,the sample to a further target in case that there are still open testrequests, G. collating, by the decision unit, gained test results withthe corresponding sample, and H. giving, by the decision unit, a reportabout the processing to the at least one host (200), wherein thecoordination between the at least one pre-analytical unit and theplurality of analytical units is coordinated by the decision unit actingas intermediary and coordinator in communication between the respectiveunits and the report is given by the decision unit to the at least onehost.
 9. The method according to claim 8, wherein step F comprises thefollowing sub-steps: F_1. processing the sample order by thepre-analytical unit by sorting and/or aliquoting the sample and puttingthe sample into an appropriate target, F_2. putting the sorted and/oraliquoted sample on an appropriate analytical unit, F_3. depending onthe sample order with sample test request information and sample relatedinformation, downloaded from the decision unit (10) to the plurality ofanalytical units, performing at least one appropriate test among thenumber of tests by at least one of the plurality of analytical units,F_4. uploading the test results from the at least one of the pluralityof analytical units to the decision unit, F_5. updating the sample orderwith respect to the uploaded test results at the decision unit, and F_6.repeating at least some of the steps until a pre-given stoppingcriterion is fulfilled.
 10. The method according to claim 8, furthercomprising the step of sorting the sample into an archive tray in casethat all test requests have been done.
 11. The method according to claim8, wherein the report given towards the at least one host comprises testresults and/or a sample order status.